Robot-Assisted Therapy in Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00917605
Recruitment Status : Unknown
Verified March 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 10, 2009
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke on various outcomes, (2) test the dose-response relations by using two different intensities (higher versus lower intensity RAT), and (3) investigate the effects of the training intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum of functioning including motor ability, motor control strategies, basic/extended daily functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the second part of study, the purposes are to define the appropriate populations for RAT and to examine the clinimetric properties of clinical measures relevant for use in robotic rehabilitation research. the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions. Finally, the investigators will examine and compare the clinimetric properties (e.g., validity and responsiveness) of the clinical measures of rehabilitation outcome to inform selection of test instruments that may detect clinically meaningful change after rehabilitation therapy.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accidents Stroke Other: Robot-assisted therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robot-Assisted Upper Limb Rehabilitation in Stroke
Study Start Date : January 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Intervention Details:
    Other: Robot-assisted therapy
    Patients will receive an intervention for 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The Robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany), will be used in this project. The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension (Hesse et al., 2003; Hesse et al., 2005). Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. Mode 3 is an active mode as in 2, but the paretic arm had to overcome an individually set, initially isometric resistance to allow the bilateral movement. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually.

Primary Outcome Measures :
  1. Fugl-Meyer Assessment [ Time Frame: before and after intervention ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 3 to 24 months onset from a first-ever unilateral stroke
  2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment
  3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers)
  4. be able to follow study instructions and perform study tasks
  5. without upper limb fracture within 3 months
  6. lack of participation in any experimental rehabilitation or drug studies during the study period
  7. willing to provide written informed consent

Exclusion Criteria:

  1. subjects exhibiting physician-determined major medical problems or poor physical conditions that would interfere with participation
  2. subjects with excessive pain in any joint that might limit participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00917605

Contact: Keh-chung Lin, ScD 886-2-33668180

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Keh-chung Lin , ScD    886-2-33668180      
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Keh-chung Lin, ScD National Taiwan University Hospltal

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital Identifier: NCT00917605     History of Changes
Other Study ID Numbers: 200903080R
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases